Automated preparation of oncology drugs in an Italian cancer center: Evaluation of productivity, errors interception, and waste reduction achieved by managing vials overfill

European Statement: 

  • Production and Compounding

Author(s): 

Caterina Donati
Giulia Moroni
Matteo Federici
Paolo Silimbani

What was done?: 

Automated preparation, operated by two robots and one gravimetric-assisted workflow system, was introduced to improve productivity and working efficiency [1,2], while reducing the risk of human errors. Furthermore, to optimize resources utilization and reduce waste, a procedure for managing overfill of drug vials during automated preparations was implemented. Indeed, manufacturers fill injectable drug vials with a volume that slightly exceeds the nominal volume (overfill) to ensure proper withdrawing and patient dosing.

Why was it done?: 

To evaluate the performances of automated preparation in the oncology pharmacy by assessing productivity, errors interception, and waste reduction achieved by managing vials overfill.

How was it done?: 

The annual throughput in terms of preparations was calculated for automated and manual preparation. Human errors intercepted during automated preparation were clustered into four groups: loading of wrong component (i.e. final container, solvent, drug product), multiple barcodes reading, failed manual reconstitution, wrong expiration date. Overfill was calculated for 17 high-cost drug vials by volumetric verifications performed by experienced pharmacy technicians. The annual number of vials used and the corresponding waste reduction due to the overfill management was determined. All data were taken from the production management software and examined over a two-year period (2019-2020).

What has been achieved?: 

In total, 82,216 preparations were compounded over two years, 72% of which with robotic systems and 28% manually prepared, either with gravimetric-assisted workflow (13%) or conventional volumetric technique (15%). Overall, automated preparation covered 85% of the total production. The human errors intercepted during automated preparation amounted to 701 in 2019 and 662 in 2020. Most errors were intercepted by robotic systems and were related to loading of wrong component (83%). Vials overfill ranged from 0.2mL (ramucirumab, eribulin, trastuzumab-emtansine, pembrolizumab, nivolumab) to 2.5mL (ipilimumab). The total waste reduction due to overfill management resulted in 1331 vials saved corresponding to 855,013€.

What next?: 

The study showed that automated preparation of oncology products represents a well-established practice in terms of productivity, and moreover ensuring interception of potential medication errors and waste reduction thanks to the overfill management

Keywords: 

  • Preparation and compounding›Compounding robots

Conflict of interest: 

I have no potential conflict of interest to disclose

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